Ignite Creation Date:
2025-12-24 @ 3:01 PM
Ignite Modification Date:
2025-12-24 @ 3:01 PM
Study NCT ID:
NCT04445259
Status:
UNKNOWN
Last Update Posted:
2021-08-04
First Post:
2020-05-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of the Treatment and Outcomes in Critically Ill Patients With COVID-19 and High Risk of Acute Kidney Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058186', 'term': 'Acute Kidney Injury'}, {'id': 'D016638', 'term': 'Critical Illness'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-06-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-08-03', 'studyFirstSubmitDate': '2020-05-27', 'studyFirstSubmitQcDate': '2020-06-23', 'lastUpdatePostDateStruct': {'date': '2021-08-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of any stage of acute kidney injury', 'timeFrame': '14 days', 'description': 'As defined by Kidney Diseases: Improving Global Outcomes (KDIGO) criteria'}], 'secondaryOutcomes': [{'measure': 'Mortality', 'timeFrame': '14-day, hospital, and intensive care unit (ICU) mortality', 'description': 'Mortality'}, {'measure': 'Renal recovery', 'timeFrame': '14 days', 'description': 'Defined by return of creatinine to \\< 1.5 times of baseline'}, {'measure': 'Percentage of patients who receive renal replacement therapy', 'timeFrame': '14 days', 'description': 'Percentage'}, {'measure': 'Percentage of participants who are dialysis dependent', 'timeFrame': 'Through study completion, an average of 90 days', 'description': 'Percentage of participants who are dialysis dependent'}, {'measure': 'Free-days of vasoactive medications and mechanical ventilation', 'timeFrame': 'Day 30', 'description': 'Days without vasoactive medications and mechanical ventilation'}, {'measure': 'Length of intensive care unit and hospital stay', 'timeFrame': 'Through study completion, an average of 90 days', 'description': 'Length of intensive care unit and hospital stay'}, {'measure': 'Number of participants with consequences following AKI', 'timeFrame': 'Through study completion, an average of 90 days', 'description': 'Congestive heart failure, Arrhythmia, Acute respiratory distress syndrome, Septic shock, Acute cardiac injury, pneumonia'}, {'measure': 'Time from illness onset to need for mechanical ventilator support', 'timeFrame': 'Through study completion, an average of 30 days', 'description': 'Time from illness onset to need for mechanical ventilator support'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['COVID', 'Acute Kidney Injury', 'Critical Illness']}, 'referencesModule': {'references': [{'pmid': '36575315', 'type': 'DERIVED', 'citation': 'Lumlertgul N, Baker E, Pearson E, Dalrymple KV, Pan J, Jheeta A, Weerapolchai K, Wang Y, Leach R, Barrett NA, Ostermann M. Changing epidemiology of acute kidney injury in critically ill patients with COVID-19: a prospective cohort. Ann Intensive Care. 2022 Dec 28;12(1):118. doi: 10.1186/s13613-022-01094-6.'}, {'pmid': '34357478', 'type': 'DERIVED', 'citation': 'Lumlertgul N, Pirondini L, Cooney E, Kok W, Gregson J, Camporota L, Lane K, Leach R, Ostermann M. Acute kidney injury prevalence, progression and long-term outcomes in critically ill patients with COVID-19: a cohort study. Ann Intensive Care. 2021 Aug 6;11(1):123. doi: 10.1186/s13613-021-00914-5.'}]}, 'descriptionModule': {'briefSummary': 'The aim is to describe the epidemiology and determine the independent risk factors for mortality and acute organ injury in AKI and to assess the impact of different treatment strategies on survival. This will allow the development of prevention strategies and design of appropriately powered intervention studies.', 'detailedDescription': "Since the outbreak of coronavirus disease 2019 (COVID-19) began in December 2019 in China, over 1 million people have been infected and over 55,000 have died worldwide, and these numbers continue to rise. Combating this pandemic requires a multidisciplinary approach from the medical research community, including translational studies to understand the pathogenesis of disease, randomized controlled trials of novel and re-purposed pharmacotherapies, and rigorously conducted epidemiologic studies that include granular patient-level data.\n\nCurrent knowledge of the clinical features and outcomes of COVID-19 is mostly limited to studies from China and Italy. In one of the larger such studies, which consisted of 1099 patients hospitalized in mainland China, only 173 (16%) were classified as having severe disease, and only 15 (1.4%) died. The study was therefore inadequately powered to determine independent risk factors for death. A larger study consisting of 72,314 patients was recently published by the Chinese Center for Disease Control and Prevention. This nationwide registry study identified several important findings, including the striking monotonic relationship between older age and greater risk of death. Important limitations of the study, however, were lack of granular patient-level data and relatively few patients (\\<5% of the cohort) who were critically ill. Among critically ill patients with COVID-19, acute mortality rates have been reported to be as high as 49-62%, underscoring the importance of studying this patient population. Data from the United Kingdom (UK) suggest that \\>50% of critically ill patients have a degree of acute kidney injury (AKI) and \\>20% need renal replacement therapy (RRT). Mortality is particularly high in those who are mechanically ventilated and need RRT (\\>75%).\n\nDetailed information about the risk of AKI, contributing factors and reasons for high mortality in critically ill COVID-19 patients is lacking. To meet this urgent need, the investigators plan to collect clinical data from \\>250 critically ill patients with COVID-19 admitted to the intensive care unit (ICU) at Guy's \\& St Thomas' Hospital. The investigators will collaborate with Dr Gupta and Prof Leaf from Harvard Medical School, Boston (US) who are leading a similar study across \\>50 sites in the United States.\n\nThe aim is to describe the epidemiology and determine the independent risk factors for mortality and acute organ injury in AKI and to assess the impact of different treatment strategies on survival. This will allow the development of prevention strategies and design of appropriately powered intervention studies."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult critically ill patients with confirmed diagnosis of COVID-19', 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Adults (aged ≥18 years)\n2. Confirmed diagnosis of COVID-19\n3. Hospitalized in the ICU for illness related to COVID-19\n4. Any of the following:\n\n * Current in-patient in ICU\n * Previous in-patient in ICU and died in ICU or hospital\n * Previous in-patient in ICU and discharged from ICU alive\n\nExclusion Criteria:\n\n1. Younger than 18 years old\n2. On chronic dialysis within the last year or on dialysis at ICU admission\n3. Functioning kidney transplant\n4. No creatinine within 48 hours of ICU admission'}, 'identificationModule': {'nctId': 'NCT04445259', 'briefTitle': 'Study of the Treatment and Outcomes in Critically Ill Patients With COVID-19 and High Risk of Acute Kidney Injury', 'organization': {'class': 'OTHER', 'fullName': "Guy's and St Thomas' NHS Foundation Trust"}, 'officialTitle': 'Study of the Treatment and Outcomes in Critically Ill Patients With COVID-19 and High Risk of Acute Kidney Injury', 'orgStudyIdInfo': {'id': '283672'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Critically Ill Patients with COVID-19', 'description': 'We plan to recruit patients who are admitted to intensive care units with COVID-19 diagnosis.'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SE1 7EH', 'city': 'London', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Marlies Ostermann, MD, PhD', 'role': 'CONTACT', 'email': 'Marlies.Ostermann@gstt.nhs.uk', 'phone': '020 71883038'}], 'facility': "Guy's & St Thomas' Hospital", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'centralContacts': [{'name': 'Marlies Ostermann, MD, PhD', 'role': 'CONTACT', 'email': 'Marlies.Ostermann@gstt.nhs.uk', 'phone': '0044 207 188 3038', 'phoneExt': '83036'}, {'name': 'Nuttha Lumlertgul, MD, PhD', 'role': 'CONTACT', 'email': 'Nuttha.Lumlertgul@gstt.nhs.uk', 'phone': '0044 207 188 3038', 'phoneExt': '83036'}], 'overallOfficials': [{'name': 'Nuttha Lumlertgul, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Guy's & St Thomas' Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Guy's and St Thomas' NHS Foundation Trust", 'class': 'OTHER'}, 'collaborators': [{'name': 'Harvard Medical School (HMS and HSDM)', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}